Alteplase for stroke
Authors: H. Mann
Journal: BMJ (2002)

# Uncertainty remains about efficacy {#article-title-2} EDITOR—The article by Lenzer and the associated commentary by Saver et al raise many serious issues, among which is the residual state of uncertainty concerning the efficacy of alteplase (tPA) in acute ischaemic stroke.1 Confronted by opposing interpretations of the aggregate data published to date and the now known baseline imbalance in the severity of stroke in the National Institute of Neurological Diseases and Stroke (NINDS) trial, doctors are presented with a conundrum: what action do the data support? The reported unwillingness of the investigators and sponsor of the National Institute of Neurological Diseases and Stroke trial to provide data for additional analysis is disturbing. Emanuel et al have described seven requirements for the ethical conduct of clinical research, among which is social and scientific value.2 Social value presupposes the public dissemination of research results. I have formulated a standard for the scientific and ethical review of trials that elaborates on this requirement.3 Implicit in this requirement is the necessity for the public dissemination of the complete dataset acquired during a clinical trial. This allows interested investigators to apply recognised analytic techniques in an attempt to resolve (or diminish) residual uncertainty concerning the clinical implications of the trial's results. This ethical requirement has not yet been met for the National Institute of Neurological Diseases and Stroke trial. 1. 1.↵1. Lenzer L . Alteplase for stroke: money and optimistic claims buttress the "brain attack" campaign [commentaries by C Warlow; JL Saver, CS Kidwell, S Starkman]. BMJ 2002; 324: 723–729. (23 March.) [OpenUrl][1][FREE Full Text][2] 2. 2.↵1. Emanuel E, 2. Wendler D, 3. Grady C . What makes clinical research ethical? JAMA 2000; 283: 2701–2711. [OpenUrl][3][CrossRef][4][PubMed][5][Web of Science][6] 3. 3.↵1. ASSERT . A standard for the scientific and ethical review of trials. www.assert-statement.org/publication.html#resultsdissem # Patients and doctors are being misled by promotional pressures {#article-title-5} EDITOR—Alteplase (tPA) is not proved for the treatment of stroke, and payment from the drug's manufacturers to research doctors degrades the premise of unbiased skill. In their commentary Saver et al disclose ties to 81 for profit companies linked to treatments for stroke.1 Sponsorship of this magnitude does not "channel the self interest of profit making companies to improving stroke care": it purchases spokesmen for manufacturers seeking to add credibility to their wares. Although sponsored … [1]: {openurl}?query=rft.jtitle%253DBMJ%26rft.stitle%253DBMJ%26rft.issn%253D0007-1447%26rft.aulast%253DLenzer%26rft.auinit1%253DJ.%26rft.volume%253D324%26rft.issue%253D7339%26rft.spage%253D723%26rft.epage%253D729%26rft.atitle%253DAlteplase%2Bfor%2Bstroke%253A%2Bmoney%2Band%2Boptimistic%2Bclaims%2Bbuttress%2Bthe%2B%2522brain%2Battack%2522%2Bcampaign%2B%2A%2BCommentary%253A%2BWho%2Bpays%2Bthe%2Bguideline%2Bwriters%253F%2B%2A%2BCommentary%253A%2BThrombolysis%2Bin%2Bstroke%253A%2Bit%2Bworks%2521%26rft_id%253Dinfo%253Adoi%252F10.1136%252Fbmj.324.7339.723%26rft_id%253Dinfo%253Apmid%252F11909792%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/ijlink?linkType=FULL&journalCode=bmj&resid=324/7339/723&atom=%2Fbmj%2F324%2F7353%2F1581.atom [3]: {openurl}?query=rft.jtitle%253DJAMA%26rft.stitle%253DJAMA%26rft.issn%253D0002-9955%26rft.aulast%253DEmanuel%26rft.auinit1%253DE.%2BJ.%26rft.volume%253D283%26rft.issue%253D20%26rft.spage%253D2701%26rft.epage%253D2711%26rft.atitle%253DWhat%2BMakes%2BClinical%2BResearch%2BEthical%253F%26rft_id%253Dinfo%253Adoi%252F10.1001%252Fjama.283.20.2701%26rft_id%253Dinfo%253Apmid%252F10819955%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [4]: /lookup/external-ref?access_num=10.1001/jama.283.20.2701&link_type=DOI [5]: /lookup/external-ref?access_num=10819955&link_type=MED&atom=%2Fbmj%2F324%2F7353%2F1581.atom [6]: /lookup/external-ref?access_num=000087046000040&link_type=ISI